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Dendreon receives interim analysis of first Phase III clinical trial of Provenge for advanced prostate cancer
Seattle | Monday, January 14, 2002, 08:00 Hrs  [IST]

Dendreon Corporation reported that it has received an interim analysis of its first Phase III clinical trial of Provenge, Dendreon's therapeutic vaccine for the treatment of prostate cancer.

An independent, third party provider of statistical analyses reported its estimate relating to the probability of a treatment difference in the primary endpoint of time to disease progression in this clinical trial in men with hormone resistant prostate cancer, an advanced form of the disease.

"This preliminary analysis is inconclusive and does not provide a sufficient basis upon which to make definitive business decisions relating to the ongoing development of Provenge, as had been the purpose of the interim analysis. It does indicate to us that it is possible, but not probable, that the primary endpoint of the study will be achieved," said Christopher S. Henney, Chief Executive Officer of Dendreon. "We look forward to a more detailed final analysis, which is anticipated to be conducted in mid-2002 when availability of the additional data required for the final analysis is expected."

"On the clinical front, we will of course continue our three ongoing Provenge Phase III clinical trials, which include two trials for the treatment of hormone resistant prostate cancer as well as an additional trial in men with hormone sensitive prostate cancer, an earlier stage of disease," said Henney.

The interim analysis addressed data in the first of two identical clinical trials of Provenge in hormone resistant prostate cancer and did not address a secondary endpoint of delay in the onset of disease related pain. Dendreon noted that as it prepares to seek marketing approval for Provenge, additional trials may be required to supplement the ongoing Phase III development program.

Dendreon Corporation is dedicated to the discovery and development of novel products for the treatment of cancer through its innovative manipulation of the immune system.

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